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VERSION:2.0
PRODID:-//Docket Clock//docket-clock.pages.dev//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Quantitative Systems Pharmacology (QSP)-Based Dose Selection
X-PUBLISHED-TTL:PT12H
REFRESH-INTERVAL;VALUE=DURATION:PT12H
BEGIN:VEVENT
UID:2026-12619-close@docket-clock.pages.dev
DTSTAMP:20261017T145145Z
DTSTART;VALUE=DATE:20260724
DTEND;VALUE=DATE:20260725
SUMMARY:FDA comments close: Quantitative Systems Pharmacology (QSP)-Based 
 Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in
  First-in-Human (FIH) Trials\; Draft Guidance for Industry\; Availability
DESCRIPTION:Notice. Federal Register 2026-12619. Docket FDA-2026-D-6539. D
 etails: https://docket-clock.pages.dev/doc/2026-12619/ Official: https://
 www.federalregister.gov/documents/2026/06/24/2026-12619/quantitative-syst
 ems-pharmacology-qsp-based-dose-selection-for-minimum-anticipated-biologi
 cal-effect
URL:https://www.federalregister.gov/documents/2026/06/24/2026-12619/quanti
 tative-systems-pharmacology-qsp-based-dose-selection-for-minimum-anticipa
 ted-biological-effect
TRANSP:TRANSPARENT
END:VEVENT
END:VCALENDAR